# K130953: Neotis; Neotis 50

- Pathway: 510(k) (Special)
- Applicant: Sbm Sciences For Bio Materials
- Decided: Jul 15, 2013 after 101 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K994337 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003) Summary page 1.
- K071155: Modification to: Biosorb Resorbable Void Filler, Science For Biomaterials (2007) Summary page 3.

## Indications for use
BIOSORB Resorbable Bone Void Filler Is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue lngrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect In all plans. In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler In tibial osteotomies.

Source page: https://510kreport.com/device/K130953
Methodology: https://510kreport.com/methodology